Live Training Course

Medical Devices - Complying With 820.250 Statistical Methods

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Course Description

Overview:
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:
Process Validation
Design Verification
Design Validation
Audits and Effectiveness Checks
Test Method Validation
Manufacturing Acceptance Sampling Plans and Inspections
Trending Data
Setting Specifications
Numerous badly needed advances in the application of statistics have occurred over the last 10-20 years. This are highlighted including:
Change-Point Analysis for CAPA Investigations and Trending
Normalized I and Laney U charts for complaint trending
Equivalency testing instead of t-tests
Methods of Validating Attribute and Destruction Test Methods
Improved methods for testing for and handling nonnormal data
Sampling Plans for precision, accuracy, and homogeneity
Why should you Attend: Two of common 483 and Warning letter items are:
Lack of valid statistical rationale
Inadequate trending of Quality data
Learn how to avoid these and how to fully comply with the statistical regulations
The majority of 483s and Warning letters are associated with lack of or inadequate procedures. Every section of 820 that mentions statistics includes a reference to a procedure. Learn how to structure your statistical procedures to ensure compliance.
Areas Covered in the Session:
Importance of a Statistical Policy
Needed procedures for areas of establishing, controlling and verifying
Important elements for each procedure
Valid statistical rational
Structuring the procedures to reduce the training burden
Deviating from procedures
Handling when there is not a procedureCourse Audience:

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There are no upcoming events listed for this course. Feel free to contact us, chat or call 1-866-540-9677 for additional info. In the mean time please Search for additional courses or view similar courses below.